# K113405: Suspension Clavicle Fracture Repair System

- Pathway: 510(k) (Special)
- Applicant: Suspension Orthopaedic Solutions, LLC
- Decided: Jan 11, 2012 after 54 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K962616 (1996). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102095: Suspension Clavicle Fracture Fixation System, Suspension Orthopaedic Solutions, LLC (2010) Summary page 1.

## Indications for use
The Suspension TM Clavicle Fracture Fixation System can be used for adult patients. The Suspension TM Clavicle Fracture Fixation plates and screws are indicated for fixation of clavicle fractures.

Source page: https://510kreport.com/device/K113405
Methodology: https://510kreport.com/methodology